Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder

Official Title: “Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder”

The primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial.

A secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are correlated with treatment efficacy.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • Subjects were started on 5mg escitalopram. Medication was increased as tolerated in weekly 2.5, 5 or 10 mg increments, until a maximally tolerated dosage or a clinical response was achieved. The final dosage ranged from 5 to 20 mg/day.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Escitalopram
  • Flexible dose (5-20mg/day) of escitalopram monotherapy.

Primary Measures

• The Clinician Administered PTSD Scale
  • Time Frame: Administered at baseline (prior to treatment) and week 12
    Safety Issue?: No

Secondary Measures

• PTSD Checklist
  • Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
    Safety Issue?: No
• Beck Depression Inventory
  • Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
    Safety Issue?: No
• Profile of Mood State
  • Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
    Safety Issue?: No
• Social Adjustment Scale
  • Time Frame: Initial, Mid-Trial and Final Assessments
    Safety Issue?: No
• Quality of Life Inventory
  • Time Frame: Initial, Mid-Trial and Final Assessments
    Safety Issue?: No

Inclusion Criteria:

• Current DSM-IV TR PTSD and a score > 40 on the CAPS, as a result of a traumatic event that occurred at least 6 months prior to evaluation.

Exclusion Criteria:

• Lifetime history of bipolar or any psychiatric disorder with psychotic features.
• Prominent suicidal or homicidal ideation.
• History of alcohol abuse/dependence within the past 3 months.
• History of drug abuse/dependence within the past 6 months.
• Subjects who plan to start a new form of psychotherapy during the protocol.
• History of sleep apnea, neurological disorder and/or current systemic illness affecting central nervous system function.
• History of myocardial infarction in the past year.
• Subjects on antipsychotic medications, systemic steroid medication, antidepressants, mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks.
• Use of Citalopram or Escitalopram within the past 6 months.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Northern California Institute of Research and Education Other

Overall Clinical Trial Officials and Contacts

Thomas C Neylan, MD Principal Investigator UCSF / VAMC / NCIRE  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01024140

Study ID Number: NEY-608

ClinicalTrials.gov Identifier: NCT01024140

Health Authority: United States: Institutional Review Board